Cosmetic Appearance of Cesarean Scar, Post Operative Pain, Surgical Site Infection
Conditions
Keywords
cesarean section incisions, silver, c-section, wound infection, scar appearance, post operative pain
Brief summary
This study will investigate whether the placement of silver impregnated dressings beginning in the OR will improve wound healing in patients undergoing cesarean delivery compared to traditional Telfa pads. This study will also explore the presumed improvement in scar integrity when silver impregnated dressings are used compared to the Telfa pads. The study will compare the percentage of patients who develop a surgical site infection after application of silver impregnated dressings versus standard Telfa dressings. Investigators will also assess the cosmetic appearance and pain of the cesarean section scar at the patient's one week and 6 week post-operative visits.
Detailed description
This is a randomized, prospective study involving 660 patients undergoing cesarean sections at Tampa General Hospital. The control group (n=330) will receive standard Telfa pad dressing and the treatment group (n=330) will receive the silver impregnated dressing. The primary objective is to compare the percentage of patients who develop a surgical site infection between the two groups at the 1-week and 6-weeks post operative visits. The secondary objective is to assess the cosmetic outcome of the cesarean incision observed at the 1-week and 6-week post-operative visits. A plastic surgery investigator will also conduct a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at 1-week and 6-weeks.The tertiary objective is to evaluate the amount of narcotic and non narcotic medicine consumed during the hospitalization and query the patient with regards to pain involving the cesarean wound at 1 and 6 week post-operative visits
Interventions
Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
DEVICETelfa pad dressing
Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Elective and emergent cesarean deliveries * Primary and repeat cesarean sections * Transverse skin incisions (Pfannenstiel) * Low transverse uterine incisions * Patients with or without the diagnosis of chorioamnionitis with antibiotic treatment prior to or after the delivery of the baby * Single and multiple gestations * Able and willing to provide written informed consent
Exclusion criteria
* Patients that did not receive routine prophylactic dose of antibiotics in the operating room. * Skin incisions other than Pfannenstiel * Uterine incisions other than low transverse * Patients with known or discovered allergy to silver or nylon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Develop a Surgical Site Infection | from post operative day #1 through post operative day 30 | A surgical site infection involving the skin and subcutaneous tissue is defined as either * The presence of a purulent discharge from the wound on inspection, or * Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or * The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Outcome of the Cesarean Section Incision | Post operative day 7 | The following instruments will be used to determine the cosmetic outcome: • The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Pain After Cesarean Delivery | Immediately post operatively to hospital discharge | The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded |
| The Number of Participants Noting Pain at the One Week Post Cesarean Visit | Post operative day 7 | Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no. |
| The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit | 6 weeks post operative | Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no. |
Countries
United States
Participant flow
Recruitment details
Recruitment was from September 2013 through June 2016. The 6 week post operative visits were completed August 2016. Recruitment was at University of South Florida South Tampa Campus, Tampa General Hospital Healthpark Genesis and Tampa General Hospital Tampa Florida Labor and Delivery Triage.
Pre-assignment details
3 patients were inadequately consented, two in the Silverlon dressing group and one in the Telfa dressing group
Participants by arm
| Arm | Count |
|---|---|
| Telfa Pad Dressing Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7. | 329 |
| Silver-impregnated Dressing Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7. | 328 |
| Total | 657 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | ineligible skin incision | 1 | 2 |
| Overall Study | ineligible uterine incision | 4 | 1 |
| Overall Study | Lost to Follow-up | 53 | 65 |
Baseline characteristics
| Characteristic | Silver-impregnated Dressing | Telfa Pad Dressing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 328 Participants | 329 Participants | 657 Participants |
| Age, Continuous | 30.9 years STANDARD_DEVIATION 5.6 | 31.0 years STANDARD_DEVIATION 5.5 | 31.0 years STANDARD_DEVIATION 5.6 |
| Region of Enrollment United States | 328 participants | 329 participants | 657 participants |
| Sex: Female, Male Female | 328 Participants | 329 Participants | 657 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 329 | 0 / 328 |
| other Total, other adverse events | 3 / 329 | 2 / 328 |
| serious Total, serious adverse events | 1 / 329 | 2 / 328 |
Outcome results
Primary
Percentage of Patients Who Develop a Surgical Site Infection
A surgical site infection involving the skin and subcutaneous tissue is defined as either * The presence of a purulent discharge from the wound on inspection, or * Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or * The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.
Time frame: from post operative day #1 through post operative day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telfa Pad Dressing | Percentage of Patients Who Develop a Surgical Site Infection | 14 Participants |
| Silver-impregnated Dressing | Percentage of Patients Who Develop a Surgical Site Infection | 15 Participants |
Comparison: With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.95% CI: [0.44, 1.96]
p-value: <0.05Mixed Models Analysis
Secondary
Cosmetic Outcome of the Cesarean Section Incision
The following instruments will be used to determine the cosmetic outcome: • The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome)
Time frame: Post operative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telfa Pad Dressing | Cosmetic Outcome of the Cesarean Section Incision | 3.8 score on a scale | Standard Deviation 1.8 |
| Silver-impregnated Dressing | Cosmetic Outcome of the Cesarean Section Incision | 3.7 score on a scale | Standard Deviation 1.8 |
p-value: <0.05see below
Secondary
Cosmetic Outcome of the Cesarean Section Incision
The following instruments will be used to determine the cosmetic outcome • The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome)
Time frame: Six weeks post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telfa Pad Dressing | Cosmetic Outcome of the Cesarean Section Incision | 11.4 score on a scale | Standard Deviation 6.5 |
| Silver-impregnated Dressing | Cosmetic Outcome of the Cesarean Section Incision | 11.6 score on a scale | Standard Deviation 6.5 |
p-value: <0.05Mixed Models Analysis
p-value: <0.05Mixed Models Analysis
Other Pre-specified
Reduction of Pain After Cesarean Delivery
The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded
Time frame: Immediately post operatively to hospital discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telfa Pad Dressing | Reduction of Pain After Cesarean Delivery | 90.0 Morphine milligram equivalent |
| Silver-impregnated Dressing | Reduction of Pain After Cesarean Delivery | 82.5 Morphine milligram equivalent |
Other Pre-specified
The Number of Participants Noting Pain at the One Week Post Cesarean Visit
Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no.
Time frame: Post operative day 7
Population: This was the number of participants that completed the form at their 7 day post- operative visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telfa Pad Dressing | The Number of Participants Noting Pain at the One Week Post Cesarean Visit | 23 Participants |
| Silver-impregnated Dressing | The Number of Participants Noting Pain at the One Week Post Cesarean Visit | 21 Participants |
p-value: <0.05Mixed Models Analysis
Other Pre-specified
The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit
Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no.
Time frame: 6 weeks post operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telfa Pad Dressing | The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit | 5 Participants |
| Silver-impregnated Dressing | The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit | 8 Participants |
p-value: <0.05Mixed Models Analysis